www.fdanews.com/articles/188823-civco-radiotherapys-immobilization-system-cleared-in-us-and-eu
CIVCO Radiotherapy’s Immobilization System Cleared in U.S. and EU
October 16, 2018
CIVCO Radiotherapy received 510(k) clearance from the FDA and a CE Mark in Europe for its Solstice SRS immobilization system, which positions the head and neck for radiotherapy treatments.
The system is customizable to position and immobilize a patient’s head and neck for radiotherapy, enabling more precise treatment.
The device includes a carbon fiber head support, thermoplastic mask and a customizable cushion.
CIVCO said the product will be available for shipment later this month.